InnFocus MicroShunt Versus Trabeculectomy Study

Primary Open Angle Glaucoma Clinical Trial

— IMS  

Official title:

A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881425
• Other study ID #: INN005
• Status: Completed
• Phase: N/A
• Start date: December 15, 2015
• Est. completion date: January 15, 2020

Study information

• Verified date: October 2022
• Source: InnFocus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

Description:

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 732
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria: - POAG on maximum tolerated glaucoma meds - Medicated =15mmHg and =40mmHg - Exclusion Criteria: - Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Procedure:
• Glaucoma Surgery
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.

Device:
• InnFocus MicroShunt
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.

Locations

Country	Name	City	State
France	Pole Ophtalmologique de la Clinique Mutualiste	Pessac	Bordeaux
Italy	Pisa University Hospital Cisanello	Pisa
Netherlands	University Eye Clinic Maastricht	Maastricht
Spain	Hospital Clínico San Carlos	Madrid
United Kingdom	Moorfields Eye Hospital	London
United States	Ophthalmic Partners of Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Specialty Eye Care	Bellevue	Washington
United States	Minnesota Eye Consultants, PA	Bloomington	Minnesota
United States	Washington Eye Physicians and Surgeons	Chevy Chase	Maryland
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Ophthalmic Surgeons and Consultants of Ohio	Columbus	Ohio
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	University of California at Davis Eye Center	Davis	California
United States	Inter-Mountain Eye Care	Eagle	Idaho
United States	Ophthalmic Consultants of Connecticut	Fairfield	Connecticut
United States	Vold Vision	Fayetteville	Arkansas
United States	Ophthalmology Associates	Fort Worth	Texas
United States	Eye Physicians and Surgeons of Arizona	Glendale	Arizona
United States	Chicago Glaucoma Consultants and CGC Eye Center	Glenview	Illinois
United States	The Robert Cizik Eye Clinic	Houston	Texas
United States	Eugene and Marilyn Glick Eye Institute	Indianapolis	Indiana
United States	UCLA Jules Stein Eye Institute	Los Angeles	California
United States	New York Eye and Ear Infirmary of Mt. Sinai	New York	New York
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma
United States	Midwest Eye Surgery Center	Omaha	Nebraska
United States	Stiles Eyecare Excellence	Overland Park	Kansas
United States	Rashid, Rice, Flynn and Reilley Eye Associates	San Antonio	Texas
United States	Glaucoma Consultants of the Capital Region	Slingerlands	New York
United States	Arizona Eye Consultants	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
InnFocus Inc.

Countries where clinical trial is conducted

United States,  France,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure	The primary effectiveness outcome is = 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up	12 months
Primary	Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure	The primary effectiveness outcome is = 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up	24 months
Secondary	Mean Diurnal Intraocular Pressure Change	Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months.	12 months
Secondary	Mean Diurnal Intraocular Pressure Change	Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months	24 months
Secondary	Number of Participants With Postoperative Interventions at 12 Months	The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit.	12 months
Secondary	Participants With Postoperative Interventions at 24 Months	The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit.	24 months